TRAMADOL 37.5 mg/325 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Tramadol hydrochloride + Paracetamol Accord, 37.5 mg + 325 mg, effervescent tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Tramadol hydrochloride + Paracetamol Accord and what is it used for
4. Important information before taking Tramadol hydrochloride + Paracetamol Accord
   1. When not to take Tramadol hydrochloride + Paracetamol Accord:
   2. Warnings and precautions
   3. Before starting treatment with Tramadol hydrochloride + Paracetamol Accord, discuss with your doctor:
   4. Tramadol hydrochloride + Paracetamol Accord and other medicines
   5. Important: This medicine contains paracetamol and tramadol hydrochloride. Tell your doctor about taking other medicines containing paracetamol or tramadol hydrochloride to avoid exceeding the maximum daily doses.
   6. Tramadol hydrochloride + Paracetamol Accord with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Since Tramadol hydrochloride + Paracetamol Accord contains tramadol hydrochloride, it should not be used during pregnancy or breastfeeding. If you become pregnant while taking Tramadol hydrochloride + Paracetamol Accord, consult your doctor before taking any more tablets.
   9. Driving and using machines
   10. Tramadol hydrochloride + Paracetamol Accord contains sodium
   11. Tramadol hydrochloride + Paracetamol Accord contains sugar and soya lecithin
5. How to take Tramadol hydrochloride + Paracetamol Accord
   1. Do not take more than 8 Tramadol hydrochloride + Paracetamol Accord effervescent tablets per day.
   2. Do not take Tramadol hydrochloride + Paracetamol Accord more frequently than your doctor has prescribed.
   3. Elderly patients
   4. Patients with kidney or liver failure, or those undergoing dialysis
   5. Method of administration
   6. Taking a higher dose of Tramadol hydrochloride + Paracetamol Accord than recommended
   7. Missing a dose of Tramadol hydrochloride + Paracetamol Accord
   8. Stopping treatment with Tramadol hydrochloride + Paracetamol Accord
6. Possible side effects
   1. Reporting side effects
7. How to store Tramadol hydrochloride + Paracetamol Accord
8. Contents of the packaging and other information
   1. What Tramadol hydrochloride + Paracetamol Accord contains
   2. What Tramadol hydrochloride + Paracetamol Accord looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: April 2023

Leaflet accompanying the packaging: patient information

Tramadol hydrochloride + Paracetamol Accord, 37.5 mg + 325 mg, effervescent tablets

Tramadol hydrochloride + Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tramadol hydrochloride + Paracetamol Accord and what is it used for
• 2. Important information before taking Tramadol hydrochloride + Paracetamol Accord
• 3. How to take Tramadol hydrochloride + Paracetamol Accord
• 4. Possible side effects
• 5. How to store Tramadol hydrochloride + Paracetamol Accord
• 6. Contents of the packaging and other information

1. What is Tramadol hydrochloride + Paracetamol Accord and what is it used for

Tramadol hydrochloride + Paracetamol Accord is a combination medicine containing two pain-relieving medicines: tramadol hydrochloride and paracetamol, which together relieve pain. Tramadol hydrochloride + Paracetamol Accord is indicated for the treatment of moderate to severe pain, if the doctor considers it necessary to administer tramadol hydrochloride in combination with paracetamol. Tramadol hydrochloride + Paracetamol Accord is intended for use in adults and adolescents over 12 years of age.

2. Important information before taking Tramadol hydrochloride + Paracetamol Accord

When not to take Tramadol hydrochloride + Paracetamol Accord:

• in case of acute alcohol intoxication, sleeping pills, painkillers, or other psychotropic medicines (used to treat mental disorders),
• in case of concomitant use of MAO inhibitors (certain medicines used to treat depression or Parkinson's disease) and for 14 days after their discontinuation,
• in severe liver failure,
• in patients with epilepsy that is resistant to treatment.

Warnings and precautions

Before starting treatment with Tramadol hydrochloride + Paracetamol Accord, discuss with your doctor:

If any of the above points apply to you, either in the past or during treatment with Tramadol hydrochloride + Paracetamol Accord, inform your doctor. The doctor will decide whether to continue treatment. Sleep apnea Tramadol hydrochloride + Paracetamol Accord contains an active substance belonging to the opioid group. Opioids can cause sleep apnea, such as central sleep apnea (shallow/broken breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The risk of central sleep apnea depends on the opioid dose. The doctor may consider reducing the total opioid dose if central sleep apnea occurs. After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If you experience any symptoms of this severe condition, seek medical attention immediately (see section 4 "Possible side effects"). Tramadol is converted in the liver by an enzyme. In some people, there is a certain variation of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of severe side effects may be higher. Stop taking the medicine and contact your doctor immediately if you experience any of the following side effects: slow breathing or shallow breathing, disorientation, drowsiness, pupil constriction, nausea or vomiting, constipation, or loss of appetite. Children and adolescents Use in children with respiratory disorders: tramadol is not recommended for use in children with respiratory disorders, as symptoms of tramadol toxicity may be exacerbated in them. If you experience any of the following symptoms while taking Tramadol hydrochloride + Paracetamol Accord, tell your doctor, pharmacist, or nurse. Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, consult your doctor, who will decide whether hormone replacement therapy is necessary.

Tramadol hydrochloride + Paracetamol Accord and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Important: This medicine contains paracetamol and tramadol hydrochloride. Tell your doctor about taking other medicines containing paracetamol or tramadol hydrochloride to avoid exceeding the maximum daily doses.

Tramadol hydrochloride + Paracetamol Accord must notbe taken concomitantly with monoamine oxidase inhibitors (MAOIs) (see "When not to take Tramadol hydrochloride + Paracetamol Accord").

Concomitant use of Tramadol hydrochloride + Paracetamol Accord with:

• carbamazepine (commonly used as an antiepileptic and also in certain types of pain, such as severe facial pain called trigeminal neuralgia);
• buprenorphine, nalbuphine, or pentazocine (opioid painkillers). The pain-relieving effect may be weakened.

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney dysfunction, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol, especially when taking maximum daily doses of paracetamol for a long time. Metabolic acidosis with a large anion gap is a serious disease that requires emergency treatment.

The risk of side effects is higher:

If you are taking certain antidepressants, Tramadol hydrochloride + Paracetamol Accord may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").

The effectiveness of Tramadol hydrochloride + Paracetamol Accord may change when taken concomitantly with:

• metoclopramide, domperidone, or ondansetron (anti-nausea and vomiting medicines),
• cholestyramine (a medicine used to lower cholesterol levels in the blood).

Your doctor will decide which medicines can be safely taken with Tramadol hydrochloride + Paracetamol Accord.

Tramadol hydrochloride + Paracetamol Accord with food, drink, and alcohol

Tramadol hydrochloride + Paracetamol Accord may cause drowsiness. Alcohol increases the feeling of drowsiness, so it is best not to drink alcohol while taking Tramadol hydrochloride + Paracetamol Accord.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Since Tramadol hydrochloride + Paracetamol Accord contains tramadol hydrochloride, it should not be used during pregnancy or breastfeeding. If you become pregnant while taking Tramadol hydrochloride + Paracetamol Accord, consult your doctor before taking any more tablets.

Breastfeeding

Tramadol passes into breast milk. Therefore, do not take Tramadol hydrochloride + Paracetamol Accord more than once while breastfeeding, or, if you take Tramadol hydrochloride + Paracetamol Accord more than once, consider stopping breastfeeding. Based on human use, tramadol is not expected to affect fertility in women and men. There are no available data on the effect of combined tramadol and paracetamol treatment on fertility. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Tramadol hydrochloride + Paracetamol Accord may cause drowsiness, which can affect your ability to drive and use tools and machines.

Tramadol hydrochloride + Paracetamol Accord contains sodium

The medicine contains 10.06 mmol (or 231.49 mg) of sodium (the main component of common salt) per effervescent tablet. This corresponds to 11.57% of the maximum recommended daily intake of sodium in the diet for adults. Tell your doctor or pharmacist if you need to take 2 or more tablets per day for a long time, especially if you are on a low-sodium diet.

Tramadol hydrochloride + Paracetamol Accord contains sugar and soya lecithin

Tramadol hydrochloride + Paracetamol Accord contains a sugar called sucrose. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. Tramadol hydrochloride + Paracetamol Accord contains soya lecithin. People allergic to peanuts or soya should not take this medicine.

3. How to take Tramadol hydrochloride + Paracetamol Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Tramadol hydrochloride + Paracetamol Accord should be taken for the shortest possible time. It is not recommended to take the medicine in children under 12 years of age. The dose should be adjusted according to the severity of the pain and the individual patient's response to treatment. Essentially, the smallest effective dose should be taken. Unless your doctor has told you otherwise, the recommended dose of Tramadol hydrochloride + Paracetamol Accord is 2 effervescent tablets for adults and adolescents over 12 years of age. If necessary, your doctor may recommend taking additional doses. The minimum time between doses must be at least 6 hours.

Do not take more than 8 Tramadol hydrochloride + Paracetamol Accord effervescent tablets per day.

Do not take Tramadol hydrochloride + Paracetamol Accord more frequently than your doctor has prescribed.

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol from the body may be delayed. In these patients, your doctor may recommend prolonging the interval between doses.

Patients with kidney or liver failure, or those undergoing dialysis

Do not take Tramadol hydrochloride + Paracetamol Accord in case of severe liver or kidney failure. In case of mild or moderate failure, your doctor may recommend prolonging the interval between doses.

Method of administration

Effervescent tablets should be taken orally. Effervescent tablets should be dissolved in a glass of water. If you feel that the effect of Tramadol hydrochloride + Paracetamol Accord is too strong (you experience drowsiness or breathing difficulties) or too weak (the pain does not subside significantly), consult your doctor.

Taking a higher dose of Tramadol hydrochloride + Paracetamol Accord than recommended

In such cases, even if you feel well, consult your doctor or pharmacist immediately. There is a risk of liver damage, the symptoms of which may appear later.

Missing a dose of Tramadol hydrochloride + Paracetamol Accord

If you miss a dose, the pain may return. Do not take a double dose to make up for the missed dose, but continue taking the medicine according to the established schedule.

Stopping treatment with Tramadol hydrochloride + Paracetamol Accord

Do not stop taking this medicine suddenly, unless your doctor has told you to do so. If you want to stop taking the medicine, discuss it with your doctor, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms). If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramadol hydrochloride + Paracetamol Accord can cause side effects, although not everybody gets them. Very common: may affect more than 1 in 10 people

• nausea,
• dizziness, drowsiness.

Common: may affect up to 1 in 10 people

• vomiting, digestive disorders (constipation, bloating, diarrhea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremors,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, abnormal feeling of well-being).

Uncommon: may affect up to 1 in 100 people

• increased heart rate or blood pressure, heart rhythm disorders,
• tingling, numbness, or prickling sensation in the limbs, ringing in the ears, involuntary muscle contractions,
• depression, nightmares, hallucinations (hearing, seeing, or feeling things that are not there), memory lapses,
• breathing difficulties,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g., rash, hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flashes, chest pain.

Rare: may affect up to 1 in 1000 people

• seizures, difficulty coordinating movements, brief loss of consciousness (fainting),
• drug dependence,
• delirium,
• blurred vision, pupil constriction,
• speech disorders,
• pupil dilation.

Unknown: frequency cannot be estimated from the available data

• decreased blood sugar levels (hypoglycemia).

The following side effects have been observed in patients taking medicines containing only tramadol hydrochloride or only paracetamol. However, if you experience any of them after taking Tramadol hydrochloride + Paracetamol Accord, tell your doctor:

• Fainting when standing up or sitting down, bradycardia (slow heart rate), collapse (fainting), changes in appetite, muscle weakness, slow or shallow breathing, mood changes, changes in activity, changes in cognitive function, worsening of asthma.
• Taking Tramadol hydrochloride + Paracetamol Accord with medicines used to thin the blood (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. In case of any prolonged or unexpected bleeding, consult your doctor immediately.
• In rare cases, a skin rash may occur, indicating an allergic reaction, which may manifest as sudden swelling of the face and neck, difficulty breathing, low blood pressure, and fainting. If you experience any of these symptoms, stop taking the medicine and consult your doctor immediately. Do not restart taking the medicine.

In rare cases, taking tramadol hydrochloride may lead to dependence and difficulties in stopping the medicine. In rare cases, in patients taking tramadol hydrochloride for some time, sudden discontinuation may cause malaise. The following symptoms may occur: agitation, anxiety, nervousness, or tremors. Patients may be overactive, have sleep problems, and gastrointestinal disorders. A very small number of patients may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, or ringing in the ears. If any of the above symptoms occur after stopping Tramadol hydrochloride + Paracetamol Accord, consult your doctor. Frequency unknown:

• hiccups,
• serotonin syndrome, the symptoms of which may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heart rate, unstable blood pressure, involuntary muscle contractions, stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramadol hydrochloride + Paracetamol Accord").

In exceptional cases, blood test results may show abnormalities, such as a low platelet count, which may lead to nosebleeds or bleeding gums. Very rarely, severe skin reactions have been reported with paracetamol use. Rarely, respiratory depression has been reported with tramadol use.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Tramadol hydrochloride + Paracetamol Accord

Do not store above 25°C. Store in the original packaging to protect from moisture. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton or blister pack. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tramadol hydrochloride + Paracetamol Accord contains

• The active substances of the medicine are tramadol hydrochloride and paracetamol. One effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other ingredients of the medicine are: anhydrous citric acid (E 330), sodium citrate monosodium (E 331), sodium bicarbonate (E 500), anhydrous sodium carbonate (E 500), povidone K 25 (E 1201), sodium saccharin (E 954), potassium acesulfame (E 950), polyethylene glycol 6000 (E 1521), orange flavor (contains cornstarch, sugar, soya lecithin (E 322), silicon dioxide (E 551), natural flavorings).

What Tramadol hydrochloride + Paracetamol Accord looks like and contents of the pack

Tramadol hydrochloride + Paracetamol Accord is a white or almost white, marbled, round, flat, beveled-edged, smooth on both sides effervescent tablet with an orange odor. The tablets are available in blister packs containing 10, 20, 30, 50, 60, or 100 effervescent tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o. ul. Taśmowa 7 02-677 Warsaw Tel: +48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp. z o.o. ul. Lutomierska 50 95-200 Pabianice Laboratori Fundació Dau C/C, 12-14. Pol. Ind. Zona Franca 08040 Barcelona Spain Accord Healthcare B.V. Winthontlaan 200 3526 KV Utrecht Netherlands Pharmadox Healthcare Limited KW20A Kordin Industrial Park Paola, PLA3000 Malta

Date of last revision of the leaflet: April 2023